FDA Questions LabCorp on Ovarian Cancer Test Service

The Gray Sheet. 2008 Aug 26, D Filmore

FDA is charging clinical lab giant Laboratory Corporation of America with marketing a test for ovarian cancer without proper clinical validation. The charge, outlined in a letter dated Aug. 7, is a rare instance of FDA getting involved in a lab's efforts to offer a new diagnostics service. It appears to reflect previously signaled but controversial plans by the agency to begin regulating lab-developed tests in certain cases. The dispatch was posted on the Web site of the Office of In Vitro Diagnostic...

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